Economic analysis of a single institutional review board data exchange standard in multisite clinical studies.

BACKGROUND: Single Institutional Review Boards (sIRB) are not achieving the benefits envisioned by the National Institutes of Health. The recently published Health Level Seven (HL7®) Fast Healthcare Interoperability Resources (FHIR®) data exchange standard seeks to improve sIRB operational efficiency. METHODS AND RESULTS: We conducted a study to determine whether the use of this standard would be economically attractive for sIRB workflows collectively and for Reviewing and Relying institutions. We examined four sIRB-associated workflows at a single institution: (1) Initial Study Protocol Application, (2) Site Addition for an Approved sIRB study, (3) Continuing Review, and (4) Medical and Non-Medical Event Reporting. Task-level information identified personnel roles and their associated hour requirements for completion. Tasks that would be eliminated by the data exchange standard were identified. Personnel costs were estimated using annual salaries by role. No tasks would be eliminated in the Initial Study Protocol Application or Medical and Non-Medical Event Reporting workflows through use of the proposed data exchange standard. Site Addition workflow hours would be reduced by 2.50 h per site (from 15.50 to 13.00 h) and Continuing Review hours would be reduced by 9.00 h per site per study year (from 36.50 to 27.50 h). Associated costs savings were $251 for the Site Addition workflow (from $1609 to $1358) and $1033 for the Continuing Review workflow (from $4110 to $3076). CONCLUSION: Use of the proposed HL7 FHIR® data exchange standard would be economically attractive for sIRB workflows collectively and for each entity participating in the new workflows.

Implementing Pharmacogenomics Testing: Single Center Experience at Arkansas Children's Hospital.

Pharmacogenomics (PGx) is a growing field within precision medicine. Testing can help predict adverse events and sub-therapeutic response risks of certain medications. To date, the US FDA lists over 280 drugs which provide biomarker-based dosing guidance for adults and children. At Arkansas Children's Hospital (ACH), a clinical PGx laboratory-based test was developed and implemented to provide guidance on 66 pediatric medications for genotype-guided dosing. This PGx test consists of 174 single nucleotide polymorphisms (SNPs) targeting 23 clinically actionable PGx genes or gene variants. Individual genotypes are processed to provide per-gene discrete results in star-allele and phenotype format. These results are then integrated into EPIC- EHR. Genomic indicators built into EPIC-EHR provide the source for clinical decision support (CDS) for clinicians, providing genotype-guided dosing.

Emergency Department Directors Are Willing to Expand Reproductive Health Services for Adolescents.

STUDY OBJECTIVE: Nearly 20 million adolescents receive emergency department (ED) care each year, many of whom have untreated reproductive health issues. ED visits represent an opportunity to provide appropriate care, however, ED physician reproductive health care practices and capabilities in the United States have not been described. We sought to characterize pediatric ED director's individual practice and ED system resources for providing adolescent reproductive health care. DESIGN, SETTING, PARTICIPANTS, AND INTERVENTIONS: We invited pediatric ED division and/or medical directors nationally to participate in an anonymous, online survey. MAIN OUTCOME MEASURES: Outcomes included ED directors' personal practice regarding providing adolescent patients reproductive health care, and their ED's resources and standard practice regarding screening adolescents for sexually transmitted infections (STIs) and other reproductive health concerns. RESULTS: One hundred thirty-five of 442 (30.5%) ED directors responded. Respondents were 73% (90/124) male, with a median of 18 (interquartile range, 13-23) years of experience and 63% (84/134) working in urban EDs. Seventy-one percent (90/130) preferred face-to-face interviews for obtaining a sexual history, but only 59% (77/130) of participants "always ask parents to leave the room for sensitive questions." Eighty-four percent (106/127) were receptive to pregnancy prevention interventions being initiated in the ED, with 75% (80/106) of those willing to provide an intervention. Only 16% (21/128) indicated their ED has a universal STI screening program, and only 18% (23/126) "always" successfully notify patients of a positive STI test. CONCLUSION: ED directors are comfortable providing adolescent reproductive health care, and many individual- and ED-level opportunities exist to provide improved reproductive health care for adolescents in the ED.

Factors associated with meaningful use incentives in children's hospitals.

BACKGROUND AND OBJECTIVE: Among children's hospitals, little is known about how barriers to electronic health record (EHR) adoption are related to meaningful use (MU) incentives. We investigated hospital success with MU incentive payments and determined associations with hospital-reported challenges and characteristics. METHODS: A survey administered to 224 Children's Hospital Association hospitals assessed a variety of potential challenges to achieving meaningful EHR use (eg, lack of access to capital) and specific MU criteria that would be challenging to fulfill (eg, implement clinical decision support rules). These results were combined with data on hospitals that received MU payments up to March 2014 and information on hospital characteristics. Associations between anticipated challenges, children's hospital type, and receipt of MU incentives were evaluated in bivariate and multivariate analyses. RESULTS: One hundred thirty-three children hospitals completed the survey (response rate 59.4%). Thirty-five percent of responding children's hospitals received MU incentive payments. The most frequently anticipated hospital challenges included the following: exchange clinical information with other providers outside your hospital system (49%), and generate numerator and denominator data for quality reporting directly from EHR (41%). Freestanding children's hospitals were more likely to indicate lack of relevance of MU criteria to pediatric care (odds ratio: 37.6 [95% confidence interval: 4.6-309.3]) and more likely to receive MU incentive payments (odds ratio: 26 [95% confidence interval: 5.2-130.6]). CONCLUSIONS: As of 2014, a minority of children's hospitals have successfully received MU incentive payments. Freestanding children's hospitals are more likely to report MU is not relevant to pediatric care and to succeed with MU incentive payments.

Impact of the meaningful use incentive program on electronic health record adoption by US children's hospitals.

OBJECTIVE: We determined adoption rates of pediatric-oriented electronic health record (EHR) features by US children's hospitals and assessed perceptions regarding the suitability of commercial EHRs for pediatric care and the influence of the meaningful use incentive program on implementation of pediatric-oriented features. MATERIALS AND METHODS: We surveyed members of the Children's Hospital Association. We measured adoption of 19 pediatric-oriented features and asked whether commercial EHRs include key pediatric-focused capabilities. We inquired about the meaningful use program's relevance to pediatrics and its influence on EHR implementation priorities. RESULTS: Of 164 general acute care children's hospitals, 100 (61%) responded to the survey. Rates of comprehensive (across all pediatric units) adoption ranged from 37% (age-, gender-, and weight-adjusted blood pressure percentiles and immunization contraindication warnings) to 87% (age in appropriate units). Implementation rates for several features varied significantly by children's hospital type. Nearly 60% of hospitals reported having EHRs that do not contain all features essential for high-quality care. A majority of hospitals indicated that the meaningful use program has had no effect on their adoption of pediatric features, while 26% said they have delayed or forgone incorporation of such features because of the program. CONCLUSIONS: Children's hospitals are implementing pediatric-focused features, but a sizable proportion still finds their systems suboptimal for pediatric care. The meaningful use incentive program is failing to promote and in some cases delaying uptake of pediatric-oriented features.

PEDSnet: a National Pediatric Learning Health System.

A learning health system (LHS) integrates research done in routine care settings, structured data capture during every encounter, and quality improvement processes to rapidly implement advances in new knowledge, all with active and meaningful patient participation. While disease-specific pediatric LHSs have shown tremendous impact on improved clinical outcomes, a national digital architecture to rapidly implement LHSs across multiple pediatric conditions does not exist. PEDSnet is a clinical data research network that provides the infrastructure to support a national pediatric LHS. A consortium consisting of PEDSnet, which includes eight academic medical centers, two existing disease-specific pediatric networks, and two national data partners form the initial partners in the National Pediatric Learning Health System (NPLHS). PEDSnet is implementing a flexible dual data architecture that incorporates two widely used data models and national terminology standards to support multi-institutional data integration, cohort discovery, and advanced analytics that enable rapid learning.

Full implementation of computerized physician order entry and medication-related quality outcomes: a study of 3364 hospitals.

This study compares quality of care measures for hospitals with fully implemented computerized physician order entry (CPOE) systems with hospitals that have not fully implemented such a system. Using a cross-sectional design, this study linked hospital quality data from the Centers for Medicare and Medicaid Services to the Health Information Management Systems Society Analytics database, which contains hospital CPOE adoption information. Performance on quality measures was assessed using univariate and multivariate methods. In all, 8% of hospitals have fully implemented CPOE systems; CPOE hospitals were more frequently larger, not-for-profit, and teaching hospitals. After controlling for confounders, CPOE hospitals outperformed comparison hospitals on 5 of 11 measures related to ordering medications and on 1 of 9 nonmedication-related quality measures. Using a large sample of hospitals, our study found significant positive associations between specific objective quality indicators and CPOE implementation.

Development approach to an enterprise-wide medication reconciliation tool in a free-standing pediatric hospital with commercial best-of-breed systems.

Medication reconciliation is essential to providing a safer patient environment during transitions of care in the clinical setting. Current solutions include a mixed-bag of paper and electronic processes. Best-of-breed health information systems architecture poses a specific challenge to organizations that have limited software development resources. Using readily available service-oriented technology, a prototype for an integrated medication reconciliation tool is developed for use in an academic pediatric hospital with commercial systems.

Development and testing of a scale to assess physician attitudes about handheld computers with decision support.

OBJECTIVE: The authors developed and evaluated a rating scale, the Attitudes toward Handheld Decision Support Software Scale (H-DSS), to assess physician attitudes about handheld decision support systems. DESIGN: The authors conducted a prospective assessment of psychometric characteristics of the H-DSS including reliability, validity, and responsiveness. Participants were 82 Internal Medicine residents. A higher score on each of the 14 five-point Likert scale items reflected a more positive attitude about handheld DSS. The H-DSS score is the mean across the fourteen items. Attitudes toward the use of the handheld DSS were assessed prior to and six months after receiving the handheld device. STATISTICS: Cronbach's Alpha was used to assess internal consistency reliability. Pearson correlations were used to estimate and detect significant associations between scale scores and other measures (validity). Paired sample t-tests were used to test for changes in the mean attitude scale score (responsiveness) and for differences between groups. RESULTS: Internal consistency reliability for the scale was alpha = 0.73. In testing validity, moderate correlations were noted between the attitude scale scores and self-reported Personal Digital Assistant (PDA) usage in the hospital (correlation coefficient = 0.55) and clinic (0.48), p < 0.05 for both. The scale was responsive, in that it detected the expected increase in scores between the two administrations (3.99 (s.d. = 0.35) vs. 4.08, (s.d. = 0.34), p < 0.005). CONCLUSION: The authors' evaluation showed that the H-DSS scale was reliable, valid, and responsive. The scale can be used to guide future handheld DSS development and implementation.